Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
NCT01874054 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2019-02-12
Summary
The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.
Conditions
- Hodgkin Disease
Interventions
- DRUG
-
brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
- DRUG
-
90 mg/m2 on Days 1 and 2 of 3-week cycles
Sponsors & Collaborators
-
Seagen Inc.
lead INDUSTRY
Principal Investigators
-
Neil Josephson, MD · Seagen Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2015-12-31
- Completion
- 2018-02-20
Countries
- United States
Study Locations
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